LATHER HAND SANITIZER- alcohol gel

LATHER HAND SANITIZER by

Drug Labeling and Warnings

LATHER HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by SOMBRA COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 65%

Uses

To decrease bacteria and viruses on the skin that could cause disease.  Recommended for repeated use, when hand washing is not available.

Warnings

Flammable. Keep away from fire or flame. For external use only: hands.

Do not use

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

When Using

Keep out of the eyes.  In case of contact with eyes, flush thoroughly with water.  Avoid contact with broken skin. Do not inhale or ingest

STOP USE

Stop use and ask a doctor if irritation and redness develop. Condition persists more than 72  hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  For children under 6, use only under adult supervision.  Not recommended for infants.

Directions

Wet hands thoroughly and allow to dry without wiping.

Other information

Do not store above 105F.  May discolor some fabrics.  Harmful to wood finishes and plastics.

Inactive ingredients

glycerin, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) peel oil, yucca schidigera stem extract, filipendula rubra extract, camellia sinensis (green tea) leaf extract.

Purpose

Antiseptic

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LATHER HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61577-1114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
ORANGE PEEL (UNII: TI9T76XD44)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
WITCH HAZEL (UNII: 101I4J0U34)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)
FILIPENDULA RUBRA WHOLE (UNII: MT26BL24AZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61577-1114-4	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020
2	NDC: 61577-1114-3	296 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020
3	NDC: 61577-1114-6	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/15/2020
4	NDC: 61577-1114-2	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/15/2020

Labeler - SOMBRA COSMETICS (097464309)

Establishment
Name	Address	ID/FEI	Business Operations
SOMBRA COSMETICS		097464309	manufacture(61577-1114)